The Food and Drug Administration on Monday approved Merck‘s new vaccine designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection called pneumonia, the drugmaker said.

Merck’s shot, called Capvaxive, specifically protects against 21 strains of that bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. It’s the first pneumococcal conjugate vaccine designed specifically for adults and aims to provide broader protection than the available shots on the market, according to the drugmaker.

Healthy adults can suffer from pneumococcal disease. But older patients and those with chronic or immunocompromising health conditions are at increased risk for the illness, especially the more serious or so-called “invasive” form. 

Invasive pneumococcal disease can lead to meningitis, an infection that causes inflammation in the area surrounding the brain and spinal cord, and an infection in the bloodstream called bacteremia. 

“If you have chronic lung disease, even asthma, you have a higher risk of getting sick with pneumococcal disease, and then being in the hospital, losing out on work,” Heather Platt, Merck’s product development team lead for the newly cleared vaccine, told CNBC in an interview. “Those are things that have a real impact on adults and children, their quality of life.”

Around 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year, Platt said. Death from the more serious form of the disease is highest among adults 50 and above, Merck said in a release in December.

Even after the FDA approval, the company’s single-dose vaccine won’t reach patients just yet. An advisory panel to the Centers for Disease Control and Prevention will meet on June 27 to discuss who should be eligible for the shot.

Platt said Merck will support the committee’s decision and is ready to supply the vaccine by late summer. 

Some analysts view Capvaxive as a key growth driver for Merck as it prepares to offset losses from its blockbuster cancer drug Keytruda, which will lose exclusivity in the U.S. in 2028. 

The market for pneumococcal conjugate vaccines is currently around $7 billion and could grow to be worth more than $10 billion over the next several years, according to a November note from Cantor Fitzgerald analysts. 

Merck’s newly approved shot could boost its competitive edge in that space, which includes drugmaker Pfizer. Merck currently markets two pneumococcal shots, but neither is specifically designed for adults. For example, the company’s existing shot Vaxneuvance is approved in the U.S. for patients 6 weeks of age and older.

Pfizer’s single-dose pneumococcal vaccine, Prevnar 20, is the current leader in the market for adults. But Merck expects its new shot to capture the majority of market share among adults, Platt said. 

“We do expect there to be rapid uptake of” Capvaxive, she said, adding that the company is confident that data on the shot will “really resonate” with clinicians and policymakers. 

Merck’s pneumococcal vaccine protects against eight strains of the bacteria that are not included in any other approved shot for the disease. Those eight strains account for roughly 30% of invasive pneumococcal disease cases in patients 65 and above, according to a release from Merck, citing CDC data from 2018 to 2021. 

The 21 strains included in Merck’s shot account for roughly 85% of invasive pneumococcal disease cases in adults 65 and above, Merck, citing the CDC data. Meanwhile, Pfizer’s Prevnar targets strains that only account for roughly 51% of cases in that age group, based on the same CDC data. 

The FDA’s approval is partly based on Merck’s late-stage trial called STRIDE-3 that pitted the vaccine against Pfizer’s Prevnar 20 in adults 18 and up who had not previously received a pneumococcal vaccine.

Correction: This story has been updated to reflect 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year.

The Federal Trade Commission on Thursday sued the largest anesthesiology provider in Texas, claiming the company has wielded monopoly power to drive up prices for patients and boost its profits.

The FTC asked a federal judge in Houston, Texas, to break up U.S. Anesthesia Partners’ alleged monopoly power and permanently bar the company from engaging in anti-competitive practices.

The agency claims that New York-based private equity firm Welsh, Carson, Anderson & Stowe founded U.S. Anesthesia Partners in 2012 to pursue an aggressive consolidation strategy that exploited Texas’ fragmented market for anesthesiology providers.

The FTC complaint says that Welsh Carson sought to make USAP the dominant provider in Texas by hoovering up the numerous independent practices that previously competed against one another, keeping prices lower.

Welsh Carson and USAP engaged in what the companies called a “roll-up,” buying nearly every large anesthesia practice in Texas, according to the complaint.

Since 2013, USAP has grown from 400 anesthesia providers at 45 health-care facilities to 4,500 providers at 1,100 facilities in 2021.

USAP has established monopoly power in Houston and Dallas, the two largest cities in Texas, and a dominant position in Austin, the state’s capital, according to the complaint.

The company has used its dominance to raise prices, raking in tens of millions of dollars, the FTC alleges.

USAP is so powerful in Austin, Dallas and Houston that it can raise prices while still gaining market share because it is difficult for competitors to enter the market, and patients typically cannot forgo anesthesia, according to the complaint.

Dr. Derek Schoppa, a USAP board member, told CNBC that the FTC’s complaint is based on flawed legal theories and a lack of medical understanding about anesthesiology.

“The FTC’s intended outcome threatens to disrupt and restrict patients’ equitable access to quality anesthesia care in Texas and will negatively impact the Texas hospitals and health systems that provide care in underserved communities,” Schoppa said in a statement.

Heather Le Biller shed 9 pounds within the first week of taking Novo Nordisk‘s blockbuster diabetes drug Ozempic – and then even more as she continued treatment. 

Le Biller, a flight attendant who lives in France, noticed her appetite quiet down while taking the weekly injection. But so did her cravings for wine, a drink she called “almost customary to pair with every dinner” in France. 

“When I was on Ozempic, it made me not want that as much anymore,” Le Biller told CNBC. “I could have a few sips of wine and just be satisfied and move on. I didn’t need multiple glasses a night, so it definitely seems to help with that.” 

Le Biller is among several patients who took diabetes and weight loss drugs and also noticed an effect on their cravings for alcohol, nicotine, opioids or even some compulsive behaviors, such as online shopping and gambling.

Those drugs – including Ozempic and its weight loss counterpart from Novo Nordisk, Wegovy – are called GLP-1 agonists, which mimic a hormone produced in the gut to suppress a person’s appetite. 

These anecdotal reports add to the growing list of potential benefits of GLP-1s beyond shedding unwanted pounds. Dramatic weight loss is the primary reason why those drugs have skyrocketed in popularity in the U.S., despite the fact that they can cost around $1,000 a month and some health insurers have stopped covering them altogether. 

“We’re prescribing these drugs and seeing this effect as a secondary benefit in patients. One of my patients even said they’re not doing as much online shopping, which is helping their wallet,” said Dr. Angela Fitch, an obesity medicine physician and president of the Obesity Medicine Association. That group is the largest organization of physicians, nurse practitioners and other health-care providers dedicated to treating obesity. 

This striking effect of GLP-1s isn’t a new idea. Several studies have demonstrated that certain GLP-1s curb alcohol intake in rodents and monkeys. 

More research needs to be done, particularly on humans, to prove that the drugs have that effect. That means it could take years before the Food and Drug Administration and other regulators worldwide approve drugs like Ozempic and Wegovy as addiction treatments. 

Novo Nordisk told CNBC in a statement that they aren’t pursuing that research.

“Pharma has this general lack of interest in investing in the addiction field” due to a perfect storm of factors, including the high stigma around addiction disorders among doctors, physicians and even patients, according to Dr. Lorenzo Leggio, clinical director of the National Institute on Drug Abuse, or NIDA.

Leggio and other scientists are working to fill the gap – and have already made strides toward confirming the potential of GLP-1s as addiction treatments.

Scientists have published nearly a dozen studies showing how GLP-1s stop binge drinking in rats and mice, reduce their desire for alcohol, prevent relapse in addicted animals and decrease alcohol consumption overall. 

Earlier studies have examined older, less potent GLP-1s such as exenatide, a drug approved for diabetes under the names Byetta and Bydureon. 

But more recent studies on semaglutide – the generic name for Ozempic and Wegovy – and another drug from Eli Lilly called dulaglutide “are the most promising” because they reduced alcohol intake in animals by 60% to 80%, according to pharmacologist Elisabet Jerlhag. 

Studies have also shown that rats that stop taking dulaglutide, which is approved for diabetes under the name Trulicity, “take weeks before they start drinking again,” she said.

Jerlhag and her colleagues at the University of Gothenburg in Sweden have studied the effect of GLP-1s on addictive behaviors for more than a decade. 

Other studies on animals have also found that GLP-1 drugs reduce the consumption of nicotine, cocaine, heroin and amphetamines. 

Few studies have been done on humans, but six clinical trials are now underway investigating how semaglutide may alter people’s drinking and smoking habits. 

The reason behind this anti-addiction effect of GLP-1s is that those drugs also affect the brain, not just the gut, according to NIDA’s Leggio. 

“The mechanism in the brain that regulates overeating is important in regulating addictive behaviors as well,” Leggio told CNBC. “There is a clear shared overlap. So it’s possible that the medications may help people with addiction by acting on that specific mechanism.”

GLP-1s specifically decrease the amount of dopamine the brain releases after people indulge in behaviors like drinking, smoking or even eating a sweet dessert, according to Dr. Steven Batash, a gastroenterologist who provides nonsurgical weight loss procedures in Queens, New York. 

Batash said dopamine is a neurotransmitter that “reinforces the pleasure” of doing those activities. When GLP-1s take away that pleasure, they also eliminate the motivation to do those activities. 

Still, NIDA’s Leggio advises against using GLP-1s off-label to reduce addictive behaviors, “simply because there’s not enough evidence in humans that they work.” 

“The animal studies are very promising and what people are reporting is very, very important, but as a scientist, I will also tell you that that’s not enough,” he told CNBC. 

Leggio said scientists need to conduct more double-blind, randomized, placebo-controlled studies on humans – or trials where both participants and researchers don’t know who is getting randomly selected to receive a placebo or an actual drug. Those types of studies are “the gold standard” for proving whether a treatment achieves a certain effect or not, he added

But even if those trials confirm that GLP-1s can reduce addictive behaviors in humans, “it will most likely work for some patients and not others,” according to Leggio. 

“We already know, as a matter of fact, that these medications and any drug overall do not work for everybody,” he said. 

For example, the only clinical study in this area investigated whether exenatide could treat alcohol use disorder in people, as compared with cognitive behavioral therapy.

But a subgroup analysis of that 2022 study found that exenatide reduced drinking in a subgroup of participants who had obesity, while the drug actually increased drinking in people who didn’t. 

The reason may be that “leaner patients” treated with exenatide experienced a larger decrease in blood sugar, which might be associated with increased cravings for alcohol, the researchers wrote in the study.

But even that hypothesis needs to be confirmed with further research. 

It’s also unclear how long the anti-addiction effect of GLP-1s will last. That’s already one complaint patients have when it comes to weight loss: People who lose weight after taking Ozempic or Wegovy tend to gain most of it – or even more – back within a few years. 

“It’s possible that some people will relapse and go back to heavy drinking if they stopped taking the medication,” Leggio said. He added that some patients will need constant treatment because addiction is a chronic disease. 

However, Leggio said there’s “nothing wrong” with a patient seeking GLP-1s to treat diabetes or obesity, in addition to an addiction disorder. 

“If you want to see whether Ozempic will help you better control the sugar in your blood but also help you with your drinking, that’s wonderful. Killing two birds with one stone,” Leggio said. “But if the only reason you want to take the drug is because of your alcohol or smoking, then you should wait for more evidence.” 

It may take years, but scientists and other health experts hope that a new class of treatments for alcohol use disorder, smoking and other addictive behaviors is on the horizon. 

“It may be that three, four or five years from now, you and I are going to say that GLP-1 agonists are wonderful for treating mild diabetes, wonderful for weight loss, and perhaps we will also say that they are wonderful for curbing addictive behaviors,” Batash told CNBC.

But even if GLP-1s get approved to treat addiction, it’s unclear how many people would take them. Uptake of existing medications for addiction is already low.

About 14 million American adults had alcohol use disorder – a disease associated with uncontrolled drinking – in the past year as of 2019. But only 1.6% used any of the three FDA-approved drugs for the condition. 

Johnson & Johnson On Monday, it said it plans to reduce its stake by at least 80% in Kenvue, the consumer health company it founded as an independent company earlier this year, via a stock exchange offering.

J&J owns 89.6% of the common shares of Kenvue, which amounts to more than 1.72 billion shares.

Related investment news

The exchange offer, also known as a split, will allow J&J shareholders to swap all or a portion of their shares for Kenvue common stock at a 7% discount. It is expected to be tax deductible, J&J said in a statement.

The company indicated that the split is voluntary for investors and is scheduled to close on the third of August. 18, which is much earlier than expected.

J&J said it received a waiver denying the stock lock period associated with Kenvue’s initial public offering in May. This lockout agreement required J&J to wait 180 days to sell any of its stock.

“We believe now is the right time to distribute Kenvue shares, and we are confident that the split is the appropriate path forward to create value for our shareholders,” J&J CEO Joaquín Duato said in a statement.

Duato added that the split will increase J&J’s focus on its pharmaceutical and medical technology businesses — both of which helped the company beat second-quarter revenue and adjusted earnings last week.

J&J first announced its intention to launch a swap offering in its second-quarter earnings report Thursday, but the company provided few details on the plan. Kenvue shares tumbled after that announcement, despite second-quarter results that also beat Wall Street estimates.

When asked about J&J’s planned swap offering Thursday, Kenvue CEO Thibaut Mongon told CNBC’s “Squawk on the Street” that the company is “pleased with the way shareholders have been received for the IPO.”

“We see a great deal of alignment among our new investors in seeing Kenvue’s potential, but I can tell you we’re absolutely ready to leave as a completely independent company,” he said.

Most consumers have cut back on spending because inflation is squeezing their wallets, but they haven’t stopped paying for brand-name health and personal care products, said Kenvue CEO Thibaut Mongon.

Mongon told CNBC on Thursday that consumers are still willing to spend on the company’s branded products — even if they cut discretionary spending at retail stores and cut back on some essential items by changing their usual purchase size or switching brands at lower prices.

the Johnson & Johnson pop-up consumer Kenvue beat second-quarter revenue and adjusted earnings estimates on Thursday, helped by resilient demand for the company’s wealth from widely recognized brands like Band-Aid, Tylenol, Listerine, Neutrogena and Aveeno.

However, the company’s share price fell after J&J announced that it would launch an exchange bid to reduce its stake in Kenvue much earlier than expected.

Kenvo also noted that “private label” penetration into the consumer health products market was stable during the quarter. Private label refers to products that are manufactured and sold under a specific retailer’s name and are sold at a lower price and are intended to compete with branded products such as Kenvue.

These spending trends could bode well not only for Kenvue, but also for other companies in the consumer health, beauty, and beverage industries that may not see consumers turning to cheaper products as often despite higher prices.

“We are now living in a volatile environment with continued consumer uncertainty and continued inflationary pressures,” Mongon told CNBC. “But I think people are very focused on their health and well-being right now.”

“They want to make sure they are doing what it takes to improve their health,” he said. “They’re looking for reliable, scientifically backed, and effective solutions to take better care of their health, and that’s what we and our brands do. It’s what we’ve been doing for a long time.”

Kenvue expects continued strong demand in the coming quarters. The company expects 2023 sales to increase between 4.5% and 5.5% over last year.

RBC Capital analyst Nick Moody expressed confidence in Kenvue’s ability to “maintain its momentum,” highlighting consumer confidence in the company’s brands, health and personal care products in general.

He noted that trade reduction pressures have increased for some companies, based on their market share changes over the past few months. Meanwhile, Kenvue has gained market share, and will likely continue to do so despite the broader environment.

“If we were going to see a decline in trade with them, we would have started to see it already,” Modi said.

Like Kenvue, some beauty and beverage companies may not see the same kind of trade declines as some core consumer sectors during the current period of macroeconomic uncertainty, according to Modi.

He said beauty products such as makeup are increasingly seen as an “affordable luxury” even as inflation squeezes consumers’ budgets.

“They don’t want to feel bad about their situation and buy cheaper makeup,” Modi said.

companies like Hollandwhich sells cosmetics, skin and hair care, and other beauty products, has benefited from the flexibility of the beauty category.

Earlier this year, Ulta said its 2022 revenue exceeded $10 billion, while annual net income exceeded $1 billion — both company records. Ulta also reported first-quarter earnings that beat expectations in May, largely driven by demand for its beauty products.

Oddity Tech, a beauty and wellness company that uses artificial intelligence to develop cosmetics, also appeared to be harnessing the power of the beauty category when it made its public market debut on Wednesday. Shares of the direct consumer platform rose 35%.

Beverage companies are also well positioned, Modi said, noting that big brand names such as Coca-Cola are not at great risk of private label penetration.

Coca-Cola’s first-quarter earnings beat expectations for higher demand for its beverages. But price increases for its products, which were implemented to mitigate the impact of inflation, also helped support results.

Monjon said consumers are turning to brands and products they “know and trust” during tough economic times.

The behavior — and a growing focus on health and well-being — is fueling demand for Kenvue products, which have been “in homes for years, decades, sometimes generations,” he said.

Modi agreed, adding that the Covid-19 pandemic has greatly increased consumers’ attachment to brands, especially those that help people take care of their health.

For example, demand for Tylenol soared and outpaced other pain relievers during the pandemic as people scrambled to stock up on essential health products.

“During the time frame of Covid, you were looking to save your family or get your kids through a difficult period of time with certain medicines and products, and I think that kind of emotional connection and sharing helped sustain the brand,” Modi told CNBC.

“Consumers tend to trust these brands during the most traumatic moments in their lives, so I think that’s why we’re seeing brands like Kinview remain so resilient despite the overall pressure,” he said.

The pandemic has made consumers more able to “take their health into their own hands at home,” added Navan Tai, an analyst at BNP Paribas Ixan.

This shift is likely to benefit Kenvue and others in the consumer health field, she said, and is “an additional differentiation from other consumer categories.”

I’ve noted that Kenvue isn’t “totally immune” from decline and private-label competition. But she said product recommendations by healthcare professionals offer “some protection”.

Third-party surveys of some healthcare practitioners in the United States from 2020 to 2022 found that Tylenol was the top adult pain medication recommended by physicians nationwide, according to an April Kenvue IPO filing.

Those surveys also found that neutrogena was the leading sunscreen and acne treatment brand in the united states, while listerine was the top dentist-recommended mouthwash.

Mongon noted during the company’s earnings call that these recommendations “ultimately foster a lifetime of loyalty to our brands, loyalty that is passed down from generation to generation.”

Medicare plans to expand its coverage of PET scans that are used to help diagnose Alzheimer’s disease, a major policy shift that could make it easier for patients to access new treatments entering the US market.

The proposal would abolish the current Medicare policy nationwide. Currently, the Seniors Program will cover one PET scan per age for patients participating in clinical trials.

Medicare’s proposal would allow regional organizations, called Medicare Administrative Contractors, to decide whether to cover the diagnostic tool. These regional contractors make coverage decisions based on whether the service is “reasonable and necessary” for a diagnosis.

Chiquita Brooks-LaSure, president of the Centers for Medicare and Medicaid Services, said in a statement Monday that the proposed policy “fulfills CMS’s commitment to allow broader coverage of this diagnostic test.” A CMS spokesperson said a final decision could come within 90 days.

Positron emission tomography scans are an important diagnostic tool that detects the presence of a protein amyloid in the brain associated with Alzheimer’s disease. Screenings are the most common way to help diagnose patients.

People on Medicare generally pay 20% of the cost of a PET scan after the deductible is met. The cost of a one-time scan would be about $313 per patient, according to one estimate in a study published in the medical journal JAMA Internal Medicine.

doctor. It’s possible for regional contractors to come to different coverage decisions for PET scans, said Sean Tunis, CMS’ former chief medical officer. But these organizations generally work together on key issues and there’s no reason to think their policies on PET scans will differ widely across the United States, said Tunis, now a consultant at Rubix Health.

Medicare’s coverage of PET scans should make it easier for patients to access new treatments like Leqembi, which was approved by the Food and Drug Administration earlier this month.

Medicare agreed to cover Leqembi’s treatment for Eisai and Biogen’s Alzheimer’s, but requires patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease with documented evidence of amyloid on the brain.

Most patients choose positron emission tomography to confirm the presence of amyloid because imaging is less invasive than alternative diagnostic tools such as spinal taps. Blood tests are also in development, and some are already in use, but not yet widely deployed.

Medicare said it would also cover other antibody therapies for Alzheimer’s with the same terms if they receive approval from the Food and Drug Administration. Eli Lilly The US Food and Drug Administration (FDA) expects to make a decision on its treatment, donanimab, by the end of the year.

The Alzheimer’s Association, a pressure group that advocates for people living with the disease, said the new policy proposed by Medicare would remove unnecessary barriers for patients. Maria Carrillo, the consortium’s chief scientific officer, called the decision “a huge step forward”.

The first over-the-counter birth control pill in the United States can remain out of reach for some women and girls because health insurance plans are not required to cover the drug in its over-the-counter form.

The U.S. Food and Drug Administration on Thursday approved Opill oral contraceptives for sale without a prescription, a landmark decision that would make the pill easier to obtain by eliminating the need to visit a doctor’s office and refill prescriptions.

A third of adult women who have tried to obtain prescription contraceptives encountered barriers to accessing them, according to a survey published in the Journal of Women’s Health in 2016.

Opel manufacturer perego It expects the pill to be available in major stores and online in early 2024. Perrigo will announce the price of Opill in two months before the pill hits stores, Perrigo CEO Fredrik Welgren said during a call with reporters Thursday.

Welgren said the company is committed to ensuring that Opel is affordable. Perrigo sets up a program to help patients, so the cost of birth control pills isn’t a barrier for women struggling to make ends meet.

But some women and girls still face obstacles in obtaining an Opel. The Affordable Care Act does not require private health insurance to cover the cost of birth control pills when used without a prescription. Most health insurance companies are required to offer birth control for free when a doctor prescribes it.

State Medicaid programs are generally not required to cover over-the-counter drugs, according to the federal Centers for Medicare and Medicaid Services.

Welgren said Perego is enlisting private insurance programs and state health care programs to offer over-the-counter Opill to women and girls for free. But she said the Affordable Care Act needs to be amended to ensure that health insurance pays for over-the-counter birth control.

It’s unclear whether insurance coverage for Opel will be in place when the pill is available in stores early next year, Welgren said. “We have some work to do to make that happen. It will take some time,” she said.

Congressional Democrats and President Joe Biden are pushing to expand access to birth control.

senator. Patty Murray, D-WA, reintroduced legislation called Accessible Affordability in the Senate in May that would require health insurance companies to offer over-the-counter oral contraceptives for free.

Biden ordered the US Department of Health and Human Services in June to ensure that all contraceptives approved by the Food and Drug Administration are available without out-of-pocket costs.

An agency spokesperson said Friday that CMS encourages health insurance to cover over-the-counter birth control products for free. The spokeswoman said the agency is working on ways to ensure that contraceptives approved by the Food and Drug Administration are available for over-the-counter use without sharing costs.

Opill is 93% effective in preventing pregnancy. It is the most effective form of over-the-counter birth control in the United States, and must be taken at the same time each day to ensure its effectiveness.

Welgren said that 15 million women in the United States who are sexually active and do not want to become pregnant use a method of contraception less effective than Opal or no method of contraception at all.

Nearly half of the 6 million pregnancies in the United States each year are unintended, according to the Food and Drug Administration. According to the agency, unintended pregnancies are associated with premature birth, which can lead to poor health outcomes for newborn babies.

Uninsured Americans pay an average of nearly $98 for a bottle Eli Lillygeneric insulin, even after the company pledged to lower the product’s list price to $25 per vial, according to a report released Thursday by the senator. Elizabeth Warren.

Eli Lilly pledged earlier this year to lower the list price of the generic insulin, Lispro, from $82.42 per vial starting May 1. The Indianapolis-based pharmaceutical company is one of the largest insulin manufacturers in the world.

The Massachusetts senator’s report surveyed more than 300 pharmacy chains and independents in the United States between June 9 and 28 to determine whether the price reduction announced by Eli Lilly “translated into real patient relief.”

The survey found that a third of pharmacies charge uninsured patients $164 or more for a bottle of Eli Lilly’s Lispro.

Seven pharmacies charged $200 per bottle or more, and two sold the product for more than $300.

Chain pharmacies charged uninsured customers an average of $123 per vial for generic insulin, compared to an average of $63 at independent pharmacies.

Eli Lilly did not immediately respond to CNBC’s request for comment on the poll.

The study findings indicate that “Eli Lilly’s promises of affordable insulin have not been delivered to uninsured patients across the country,” Warren said in a statement.

She said the data also shows that Congress needs to take more steps to rein in excessive pricing, such as capping insulin fees at $35 per month for all patients, regardless of their insurance status.

President Joe Biden’s Inflation Reduction Act currently sets co-insulin amounts at $35 per month for people covered by Medicare.

“My new report confirms that far too many uninsured Americans do not have access or cannot afford to pay astronomical prices for life-saving universal insulin — lawmakers need to step up and take action,” Warren said in a press release.

Insured Americans usually pay a fraction of the list price of insulin. But uninsured people often have to pay the full cost, which could force them to ration or stop taking a life-saving diabetes treatment.

Nearly 30% of uninsured diabetics reported skipping insulin doses, taking less than prescribed or delaying purchases within the past year, Warren said, citing a 2022 study conducted by researchers from Harvard University and other institutions.

“No American should ever be forced to choose between life-saving medications, such as insulin, and their ability to pay for food, shelter, and their daily needs,” Warren said.

Earlier this year, Eli Lilly, Sanofi And Novo Nordisk is committed to reducing the list prices of the most commonly prescribed types of insulin by at least 70% later in 2023.

Eli Lilly and Sanofi also set monthly insulin costs at $35 for people with private insurance.

The three companies together control 90% of the global insulin market.

Their commitments were met with praise from lawmakers and Biden, who was pleased that the companies were finally heeding the calls to help make diabetes care more affordable in the United States.

But the Warren poll raises questions about the effectiveness of cost-cutting efforts.

About 37 million people in the United States, or 11.3% of the country’s population, have diabetes, according to the Centers for Disease Control and Prevention.

The American Diabetes Association said nearly 8.4 million people with diabetes are insulin dependent.

Medicare has agreed to pay for Leqembi’s treatment for Alzheimer’s disease, a major turning point for patients diagnosed with the early stages of the disease.

Leqembi is the only drug on the market now that has been shown to slow the progression of early-stage Alzheimer’s disease in a clinical trial. The monoclonal antibody, given twice monthly through an IV, slowed cognitive decline by 27% over the course of 18 months in the trial.

Leqembi is made by the Japanese pharmaceutical company Eisai and its partner Biogenheadquartered in Cambridge, Massachusetts.

Medicare’s decision to cover Leqembi, which came moments after the US Food and Drug Administration approved the drug Thursday, promises to make treatment more accessible to patients.

Medicare coverage is critical for most patients to have any hope of being able to afford Leqembi. Eisai priced Leqembi at $26,500 a year before insurance coverage, which is too expensive for Medicare patients, whose average income is about $30,000.

Medicare foots the majority of the bill, though many patients will still face several thousand dollars out of their own pockets.

Patients on traditional Medicare will pay 20% of Leqembi’s bill, according to the federal Centers for Medicare and Medicaid Services. That means those patients could see an annual bill of more than $5,000, according to an estimate from KFF, a nonprofit group that researches healthcare issues.

People with Medicare Advantage plans typically pay 20% more for drugs like Leqembi, up to the out-of-pocket limit, which was about $5,000 on average for in-network services, according to the KFF.

Patients with supplemental insurance such as Medigap or Medicaid may pay less, according to the KFF.

People with modest means may not be able to afford an out-of-pocket Leqembi even with Medicare coverage, said Tricia Newman, a Medicare expert at KFF.

Newman said this is particularly worrisome because blacks and Hispanics are more likely to develop Alzheimer’s disease but are likely to have lower incomes.

If demand for Leqembi is high, there are also concerns that patients could face long waiting times to see specialists and receive injections.

Medicare has certain conditions that must be met for patients to be eligible for Leqembi coverage.

To be diagnosed with Alzheimer’s disease or mild cognitive impairment, patients should undergo a cognitive assessment and undergo a positron emission tomography scan or a spinal tap to detect the amyloid protein associated with the disease. PET scans are the most common way to detect amyloid because they are less invasive.

Medicare currently covers one PET scan per age for amyloid detection. A spokesperson for the agency said CMS is reconsidering this policy and plans to release a proposed rule soon.

The requirement for clinicians to enter patient information into the registration system is controversial. The Alzheimer’s Association and some members of Congress are concerned that the requirement to collect data creates unnecessary red tape for patients to receive treatment.

The federal Centers for Medicare and Medicaid Services has created a nationwide portal that is supposed to make it easier for doctors to enter required information about their patients. CMS has released a video showing clinicians how to navigate the system:

Doctors can access free registration on this website.

doctor. The record is simple and unlikely to be burdensome for patients and doctors, said David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota.

Patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease need to talk to their doctor about whether Leqembi’s benefits outweigh the risks, according to CMS.

Although Leqembi slightly slowed cognitive decline in clinical trials, the treatment also carries serious risks of brain swelling and bleeding. In the trial, 13% of patients given Leqembi had swelling and 14% had bleeding.

Swelling and bleeding were usually mild, with no obvious symptoms, but these episodes can be fatal, according to an independent Food and Drug Administration review of clinical trial data. When symptoms do appear, they include headache, confusion, dizziness, vision changes, and nausea.

People who have two copies of a gene mutation called APOE4 are at increased risk of swelling and bleeding and patients should be tested to confirm if they have the mutation before taking Leqembi, according to the US Food and Drug Administration. A CMS spokesperson said Medicare covers testing for the APOE4 mutation.

And according to the Food and Drug Administration, patients who take anticoagulants appear to be more likely to have bleeding in the brain.

Three patients who received Leqembi died in the trial, although the Food and Drug Administration could not determine if these deaths were related to the treatment.

Patients who have been appropriately diagnosed and informed should be able to decide for themselves whether they want to take Leqembi after weighing the benefits of the treatment against the risks of potentially serious side effects, Knopman said.